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Medical News and Perspectives
December 15, 2004

FDA Approves Ultrasound Fibroid Therapy

JAMA. 2004;292(23):2826. doi:10.1001/jama.292.23.2826

The US Food and Drug Adminstration has approved the first noninvasive, potentially ablative therapy for uterine fibroids. While hysterectomy remains the only definitive therapy for these benign tumors, the combination magnetic resonance imaging (MRI) and ultrasound technology, called the ExAblate 2000 System, could offer selected patients a less invasive alternative to surgery.

Uterine fibroids are found in approximately 20% to 40% of women over the age of 35 years, with an estimated incidence as high as 75% in certain high-risk populations. While many such tumors are asymptomatic, some are associated with significant and disabling symptoms, ranging from prolonged menstrual periods to urinary frequency and lower back and pelvic pain.

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